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Data / Medical devices / United States / Lumiquick Diagnostics, Inc.

Lumiquick Diagnostics, Inc.: FDA-registered device maker in Santa Clara, CA, United States, 28 510(k) clearances

Lumiquick Diagnostics, Inc. is registered with the FDA (registration 3005984081) in Santa Clara, CA, United States. It lists 60 device types. The FDA files 28 510(k) clearances under its listings, the newest dated May 22, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Lumiquick Diagnostics, Inc.
FDA registration number
3005984081
Address
2946 Scott BLVD., Santa Clara, CA, United States, 95054
Owner or operator
LUMIQUICK DIAGNOSTICS, INC. (9093981)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessor
First device listed
December 5, 2007
Registered through
2027
Brand names listed
QuickProfile, QuickProfile HCG Tests, QuickProfile Rapid Single/Multi-Drug Test Cup, QuickProfile Rapid Single/Multi-Drug Test DipCard, QuickProfile Rapid Urine Fentanyl (FTL) Test Card, QuickProfile Rapid Urine Fentanyl (FTL) Test DipCard, QuickProfile Rapid Urine Fentanyl (FTL) Test Strip, QuickProfile S. typhi IgG/IgM Duo Test and more

Devices it lists

DeviceProduct codeClassRoleSource
Amplifier And Signal Conditioner, BiopotentialDRR2Repackager or relabeleraccessdata.fda.gov
Antigens, All Groups, Streptococcus Spp.GTY1Manufacturer for exportaccessdata.fda.gov
Antigens, Cf (Including Cf Control), Adenovirus 1-33GOD1Manufacturer for exportaccessdata.fda.gov
Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.GNC2Manufacturer for exportaccessdata.fda.gov
Applicator, Absorbent Tipped, SterileKXG1Manufacturer for exportaccessdata.fda.gov
Atp And Creatine Kinase (Enzymatic), CreatineJLB1Manufacturer for exportaccessdata.fda.gov
Biosensor, Immunoassay, MyoglobinMVE2Manufacturer for exportaccessdata.fda.gov
C-Reactive Protein, Antigen, Antiserum, And ControlDCK2Repackager or relabeleraccessdata.fda.gov
Coronavirus Antigen Detection Test System.QKPNComplaint file establishmentaccessdata.fda.gov
Devices Detecting Influenza A, B, And C Virus AntigensPSZ2Manufacturer for exportaccessdata.fda.gov
Enzyme Immunoassay, AmphetamineDKZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BarbiturateDIS2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, BenzodiazepineJXM2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, CannabinoidsLDJ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Cocaine And Cocaine MetabolitesDIO2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, MethadoneDJR2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total ThyroxineKLI2Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, OpiatesDJG2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PhencyclidineLCMUManufacturer, Repackager or relabeleraccessdata.fda.gov
Enzyme Immunoassay, PropoxypheneJXN2Repackager or relabeleraccessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, RotavirusLIQ1Manufactureraccessdata.fda.gov
Enzyme Linked Immunosorbent Assay, Coccidioides ImmitisMIY2Contract manufactureraccessdata.fda.gov
Ferritin, Antigen, Antiserum, ControlDBF2Repackager or relabeleraccessdata.fda.gov
Gas Chromatography, MethamphetamineLAF2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Helicobacter PyloriLYR1Contract manufactureraccessdata.fda.gov
Ige, Antigen, Antiserum, ControlDGC2Repackager or relabeleraccessdata.fda.gov
Immunoassay Method, Troponin SubunitMMI2Repackager or relabeleraccessdata.fda.gov
Kit, Test, Pregnancy, Hcg, Over The CounterLCX2Repackager or relabeleraccessdata.fda.gov
Legionella, Spp., ElisaMJH2Manufacturer for exportaccessdata.fda.gov
NEDNEDManufacturer for exportaccessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate CancersLTJ2Manufacturer for exportaccessdata.fda.gov
Radioimmunoassay, Follicle-Stimulating HormoneCGJ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Luteinizing HormoneCEP1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)CFT1Reprocessoraccessdata.fda.gov
Radioimmunoassay, Testosterones And DihydrotestosteroneCDZ1Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating HormoneJLW2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Total TriiodothyronineCDP2Repackager or relabeleraccessdata.fda.gov
Radioimmunoassay, Tricyclic Antidepressant DrugsLFG2Repackager or relabeleraccessdata.fda.gov
Reagent, Coronavirus SerologicalQKONContract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Reprocessoraccessdata.fda.gov
Reagent, Occult BloodKHE2Manufacturer for exportaccessdata.fda.gov
Replacement, Ossicular Prosthesis, TotalETA2Repackager or relabeleraccessdata.fda.gov
System, Test, Beta-2-Microglobulin ImmunologicalJZG2Manufacturer for exportaccessdata.fda.gov
Test Reagents For Ethyl AlcoholDMJ2Manufacturer for exportaccessdata.fda.gov
Test, Amphetamine, Over The CounterNFT2Repackager or relabeleraccessdata.fda.gov
Test, Barbiturate, Over The CounterPTH2Repackager or relabeleraccessdata.fda.gov
Test, Benzodiazepine, Over The CounterNFV2Repackager or relabeleraccessdata.fda.gov
Test, Cannabinoid, Over The CounterNFW2Repackager or relabeleraccessdata.fda.gov
Test, Cocaine And Cocaine Metabolites, Over The CounterNFY2Repackager or relabeleraccessdata.fda.gov
Test, Methadone, Over The CounterPTG2Repackager or relabeleraccessdata.fda.gov
Test, Methamphetamine, Over The CounterNGG2Repackager or relabeleraccessdata.fda.gov
Test, Opiates, Over The CounterNGL2Repackager or relabeleraccessdata.fda.gov
Test, Propoxyphene, Over The CounterQBF2Repackager or relabeleraccessdata.fda.gov
Test, Qualitative, Detection Of Dengue Igm And Igg AntibodiesNWYNManufacturer for exportaccessdata.fda.gov
Test, Tricyclic Antidepressants, Over The CounterQAW2Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, BarbiturateDKX2Manufactureraccessdata.fda.gov
Thin Layer Chromatography, MethamphetamineDJC2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, MorphineDNK2Repackager or relabeleraccessdata.fda.gov
Thin Layer Chromatography, PropoxypheneDPN2Manufacturer for exportaccessdata.fda.gov
Visual, Pregnancy Hcg, Prescription UseJHI2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Zika Virus Serological Reagents (Emergency Use)PYSNManufacturer for exportaccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 22, 2024K241100Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test DipcardNGLSubstantially EquivalentCo-Innovation Biotech Co., Ltd.accessdata.fda.gov
January 17, 2024K232732Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50LDJSubstantially EquivalentCo-Innovation Biotech Co., Ltd.accessdata.fda.gov
April 5, 2022K213808Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test MidstreamLCXSubstantially EquivalentCo-Innovation Biotech Co., Ltd.accessdata.fda.gov
September 25, 2020K202567Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
December 3, 2018K182701Wondfo T-Cup Multi-Drug Urine Test CupNFTSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
June 2, 2017K162395MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIOSubstantially EquivalentMp Biomedicals, LLCaccessdata.fda.gov
April 26, 2016K153050Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test DipcardDJGSubstantially EquivalentCo-Innovation Biotech Co., Ltd.accessdata.fda.gov
October 18, 2013K130213QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICELDJSubstantially EquivalentLumiquick Diagnostics, Inc.accessdata.fda.gov
July 21, 2006K051958MP RAPIDOXY TEST STRIP, MODEL 07RD-7073DJGSubstantially EquivalentMp Biomedicals, LLCaccessdata.fda.gov
April 8, 2005K043443ONE STEP HCG URINE PREGNANCY TESTLCXSubstantially EquivalentGuangzhou Wondfo Biotech Co., Ltd.accessdata.fda.gov
May 17, 2004K033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062DKZSubstantially EquivalentRapid Diagnostics, Inc.accessdata.fda.gov
June 13, 2003K030211RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016DKXSubstantially EquivalentIcn Biomedicals, Inc.accessdata.fda.gov
December 19, 2002K022660BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117DRRSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
November 22, 2002K023252RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020DJRSubstantially EquivalentIcn Biomedicals, Inc.accessdata.fda.gov
May 6, 2002K020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)DJGSubstantially EquivalentRapid Diagnostics, Inc.accessdata.fda.gov
January 8, 2002K013062BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KITMMISubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
July 20, 2001K003851BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119DCKSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
April 20, 2001K003809RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELSDKZSubstantially EquivalentRapid Diagnostics, Inc.accessdata.fda.gov
October 2, 2000K002294BIOCHECK TESTOSTERONE EIA, MODEL BC-1115CDZSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
September 24, 1999K992517BIOCHECK FERRITIN ELISA MODEL BC-1025DBFSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
September 21, 1999K992528BIOCHECK IGE ELISA, MODEL BC-1035DGCSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
August 9, 1999K992138MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIESETASubstantially EquivalentMicromedics, Inc.accessdata.fda.gov
July 22, 1999K991741BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027JHISubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
June 22, 1999K991146TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001JLWSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
June 22, 1999K990993BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003JLWSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
June 2, 1999K991432BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007KLISubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
June 2, 1999K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005CDPSubstantially EquivalentBiocheck, Inc.accessdata.fda.gov
June 5, 1998K981770RAPIDHCG PREGNANCY TESTJHISubstantially EquivalentRapid Diagnostics, Inc.accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
March 4, 201467665Class IITerminatedSyphilis Test Strip (Serum) LumiQuick, Santa Clara, CA 95054Products shipped to US locations that do not have approved applications for PMA, IDE or 510(k) clearance.accessdata.fda.gov

Compare with other makers

Updated May 22, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.